A Pivotal, Single-arm, Multi-centre, Prospective Clinical Investigation to Assess the Efficacy and Safety of the FastWire REvascularisation of Extremities, (For LOWer Limbs) (FREEFLOW).
Versono Medical Ltd
Summary
This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)
Description
Single-arm, multi-center, pivotal study to assess the efficacy and safety of the FastWire System in patients who have a chronic total occlusion in their peripheral vasculature causing an ischemic limb. The enrollment will consist of up to 65 patients meeting the inclusion/exclusion criteria.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria: Subjects who meet all the following criteria are eligible for this clinical investigation: 1. The patient signed and dated an Informed Consent Form. 2. Aged between 18 years and 85 years (inclusive). 3. Severe claudication assessed as Rutherford category 3 or CLTI assessed as Rutherford category 4 or 5 LEAD. Angiographic Inclusion Criteria Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on the visual determination of qualification imaging taken at the time of the procedure. Subject must meet ALL the following ang…
Interventions
- DeviceFastWire System - Peripheral
The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.
Locations (6)
- EndoVascular ConsultantsWilmington, Delaware
- Vascular & Embolization SpecialistsCocoa, Florida
- Vascular Institute of the MidwestDavenport, Iowa
- Cardiovascular Institute of the South-ASCGray, Louisiana
- Dearborn CardiologyDearborn, Michigan
- Vascular Institute of ChattanoogaChattanooga, Tennessee